In 2012, a Massachusetts pharmacy shipped out thousands of contaminated steroid injections; the drugs caused an outbreak of meningitis. Recently, the Food and Drug Administration (FDA) has issued warnings to doctors about a Texas facility whose drugs may be contaminated as well.
Unique Pharmaceuticals, located in Temple, Texas, is a compounding pharmacy: their drugs are customized to the physician who requests them. NuVision Pharmacy in Dallas is another compounding pharmacy, and the FDA has issued warnings about their production as well. In both cases, the FDA found that the conditions of the plants were not sterile enough; they believe that contamination is possible because of it.
Both NuVision and Unique Pharmaceuticals have recalled all sterile drugs and stopped production of any medications still to be produced. The FDA states that so far, no illnesses have been reported in conjunction with the medications.
The risks of contaminated injections and compounded drugs
Aside from the potential for a contaminated drug to fail at its job, people who receive contaminated injections are at risk for a bevy of other health problems, including infection and allergic reactions. In the 2012 outbreak, at least 30 people died from meningitis or from an associated problem with the injections.
Injections – or any drugs – that are made by a compounding facility face some different problems, as these facilities are not regulated by the FDA. While compounding pharmacies may be regulated by individuals states, and follow guidelines set forth by the U.S. Pharmacopeial Convention (USP), most compounding drugs are made in small batches or for specific patients, and therefore don’t warrant full FDA regulation. The pharmacists use their own list of recipes to compound the drugs, and doctors are supposed to double check the ingredients, but negligence on behalf of one party could lead to a problem with the drug.
However, about 50 of the facilities have registered with the FDA voluntarily – a move that allowed the FDA to recall drugs produced by Unique Pharmaceuticals.
For more information about contaminated injections, or to learn more about the compounding process, please visit Plaxen & Adler., P.A. We’re a trusted authority in Maryland in the area of medical malpractice, and we encourage you to learn more on our website.